Swabbable needle-free injection port valve system with zero fluid displacement

ABSTRACT

An improved needle-free intravenous injection port assembly is disclosed. Embodiments include a boot valve with a helical surface, a boot valve and septum which mate with mechanical interference, a spike with a rough outer surface coated with a lubricant, a septum having a shoulder and a single continuous swabbable surface, a septum and a boot valve which are pre-punctured, a septum with a frustroconical extension and a combination single piece septum and boot valve. The injection port assembly provides zero fluid displacement during coupling and uncoupling.

This application is a divisional of application U.S. Ser. No.11/341,119, filed Jan. 26, 2006, now U.S. Pat. No. 7,530,546 which is acontinuation-in-part of U.S. Ser. No. 10/756,601, filed Jan. 13, 2004,and issued on Feb. 7, 2006, as U.S. Pat. No. 6,994,315, the completedisclosures of which are hereby incorporated herein by reference. Thisapplication also relates to U.S. Pat. No. 6,113,068, issued Sep. 5,2000, the complete disclosure of which is hereby incorporated byreference herein.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to medical intravenous administration lineconnectors. More particularly, this invention relates to needle-freeintermittent injection ports for the safe infusion and/or aspiration offluids in intravenous and blood administration therapy.

2. State of the Art

Intravenous fluid therapy for parenteral administration or bloodsampling in healthcare facilities routinely uses intermittent injectionport connectors. These connectors or adapters are connected to avascular access device such as a peripherally inserted central venouscatheter (PICC), central venous catheter (CVC), femoral catheter, Huberneedle for implantable ports, peripheral intravenous catheter (PIV),catheter and intravenous extension set, or intravenous administrationset. The intermittent injection port connector allows the infusiontherapist a means to infuse fluids or aspirate the patient's bloodthrough the connector without having to stick the patient with a needleeach time.

Traditionally, healthcare providers worldwide have used an intermittentinjection port connector utilizing a latex septum or barrier requiring ahollow steel needle attached to a syringe or intravenous line set topierce the resilient latex septum opening up a fluid channel to thepatient. Since the discovery in the mid-1980's of the virus that causesAIDS, and the possibility of this virus being transmitted to thehealthcare provider via an accidental needlestick injury, a major changewithin the medical device industry has taken place. Although hepatitis Band C are still the leading concern among healthcare professionals viaan accidental needlestick injury, the emotional concern of thepossibility of contracting AIDS through contaminated needles has beenthe catalyst for change in the industry.

Since the mid 1980's, various design innovations have solved theaccidental needlestick injury crisis among healthcare professionals.However, two critical catheter management issues have been on the rise;i.e., interluminal thrombotic catheter occlusions, and catheter relatedblood stream infections (CRBSIs). Now that healthcare professionals arecomfortable that they are protected from accidental needlestick injurieswhen they use these types of safety injection port systems, they arebeginning to focus on the patient safety aspects of these products;i.e., to overcome occlusions and CRBSIs. It is clear that a newgeneration of intermittent injection port designs is needed to improveand resolve concerns such as microbial ingress, ineffective patientfluid pathway protection, negative fluid displacement retrograding bloodup into the catheter lumen, septum seal integrity, and other criticalfunctional features.

Co-owned U.S. Pat. No. 6,113,068 focuses on improving upon the criticalmicrobial barrier performance and functional attributes important foroverall patient safety. After manufacture, it effectively provides asingle piece injection port with standard male-luer connectors, i.e.universal access. No extra adapters, components, or end caps arerequired, thereby reducing the overall cost to deploy the systemthroughout the healthcare facility. The upper septum is swabbable andeasy to disinfect. There are no gaps between the septum and the outerbody opening, thereby improving septum seal integrity. This preventsgross particulate contamination from entering into the internal body ofthe valve, thereby minimizing downstream contamination. The injectionport cannot be used with non-safety hollow bore needles, therebycomplying with OSHA guidelines and mandates. The double microbialbarrier design is an effective barrier to pathogen ingress. Thecombination of the double resilient barriers (the upper resilient septumand the lower resilient boot valve) and their association with thehollow bore spike and centering component significantly reduce thenegative fluid displacement to a negligible 0.0035 mL, which issignificantly reduced relative to all other currently availableneedle-free connector systems. The plastic centering component capturesboth barriers allowing the double barriers to move freely along theinner wall of the outer body and to keep the slits axially aligned withthe spike tip and shaft. The straight-through fluid path eliminates thetortuous paths found in many prior art devices. Priming volume isreduced to only 0.034 mL of fluid which is one of the smallest volumesfor swabbable injection port connectors. Activation force to fullyaccess the valve is approximately 5.5 lbs, an acceptable amount for theclinician while providing excellent snap-back and resealingcharacteristics. In the device described in my prior patent, fluid flowat gravity averaged 7,500 mL per hour thereby exceeding the ISO standardof 6,000 mL per hour with the fluid source at one meter above the valve.In the manufacturing process, after assembly of all the components andthe sonic-welding of the two outer bodies, an ISO male luer fixturecould be used to initially pre-puncture the two silicone barriers. Asthe male luer fixture is attached to the injection port assembly, theinternal spike punctures the two silicone barriers and distributes theliquid silicone lubricant along the puncture axes in the two barriers.

Although the invention which is described in U.S. Pat. No. 6,133,068improved upon many of the desired patient safety attributes for aswabbable injection port connector system, the prior design may beimproved.

SUMMARY OF THE INVENTION

It is therefore an object of the invention to provide a needle-freemedical valve injection port which is safe, efficacious, and easy touse.

It is also an object of the invention to provide an injection port valvesystem which is swabbable and provides an excellent microbial ingressbarrier protection.

It is another object of the invention to provide an injection port valvesystem which has less than 0.002 mL fluid displacement during both the“connection to” and “disconnection from” the medical valve.

It is an additional object of the invention to provide an injection portvalve system which has a zero fluid displacement to minimize blood beingrefluxed or retrograded into a vascular access device lumen during boththe “connection to” and “disconnection from” the medical valve. Forpurposes herein, the term “zero fluid displacement” is defined as fluiddisplacement of 0.000 mL with a small tolerance of ±0.002 mL uponattachment (connection) and detachment (disconnection) of the port valvesystem from a line connector.

It is a further object of the invention to provide an injection portvalve system which has improved snap-back characteristics in repeateduse over the life cycle of the product to minimize fluid leakage and/ormicrobial ingress.

Another object of the invention is to provide an injection port valvesystem which minimizes dead space within the fluid pathway therebyreducing the probability of downstream contamination and improving theflushing capabilities of the medical valve.

A further objective of the invention is to provide an injection portvalve system which has excellent leak resistant characteristics ofrepeated use during its life cycle.

An additional object of the invention is to provide an injection portvalve system which improves the lubrication of the spike shaft, spiketip, and the puncture axis geometry to minimize coring of the tworesilient microbial barriers during repeated use.

Yet another object of the invention is to provide an injection portvalve system which has improved back-pressure leak resistantcapabilities.

It is even a further object of the invention to provide an injectionport valve system which is easy to use and activate by reducing theoverall activation force required.

In accord with these objects, which will be discussed in detail below,an injection port valve system according to the invention has five totalcomponents: an upper plastic outer body with ISO compliant threads (“thefemale luer body”), a lower plastic outer body with an integrally formedunitary hollow spike and an ISO compliant male luer lock in fluidcommunication with the spike (“the spike body”), an upper resilientbarrier (“the septum”), a plastic centering and barrier cage (“theH-guide”), and a lower resilient barrier (“the boot valve”).

The septum and the boot valve are designed to minimize fluid leakagefrom the patient side of the valve at high pressure (e.g. when the IVtubing is kinked or clogged) and to prevent microbial ingress from theoutside environment into the patient's bloodstream. The septum and theboot valve are joined at the H-guide. The valve also includes a hollowspike having an open tip. The spike preferably has a bullet-nose bridgestructure with at least two fluid opening channels or an unobstructedopening. The boot valve completely covers the spike giving the valve thefirst barrier of defense against fluid leakage to the outsideenvironment and the second barrier of defense against microbial ingressfrom the outside environment into the patient's bloodstream. The septumprovides the first barrier of defense against microbial ingress from theoutside environment into the patient's bloodstream, and the secondbarrier of defense against fluid leakage to the outside environment.There is no dead space between the septum and the boot valve. There isalso no dead space between the spike tip bridge and the inner wall ofthe boot valve. According to one embodiment, there is an internal ringseal protruding from the inner wall of the boot valve positioned justbelow the spike tip opening that has an interference fit with the spikeshaft to prevent fluid blow-by down the outer surface of the spike.There is preferably an interference fit between the septum and the bootvalve, as well as an interference fit between the H-guide and the tworesilient barriers. The boot valve is sufficiently resilient to move thetwo resilient barriers and the H-guide immediately back to the originalslightly compressed state upon the removal of a male luer connector fromthe female luer. The septum is preferably provided with an outershoulder or flange, a tapered end facing the boot valve, a matchingcontour mating surface for mating with the boot valve, and a singlecontinuous swabbable surface facing away from the boot valve andexposing the septum surface to the outside. The boot valve is preferablyprovided with a spring-like “helical” external surface. The septum andthe boot valve are preferably pre-punctured with a knife blade having awidth of approximately 0.056 inches which is lubricated with afluorosilicone liquid formulation. The surface of the spike ispreferably roughened and coated with a fluorosilicone lubricant.

The medical valve of this invention has many features; no single one issolely responsible for its improved microbial and functional attributes.The system achieves a zero fluid displacement and an improved microbialingress barrier.

Additional objects and advantages of the invention will become apparentto those skilled in the art upon reference to the detailed descriptionin conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an exploded perspective view of a first embodiment of theinvention;

FIG. 2 is a longitudinal cross-sectional view of the assembledcomponents of FIG. 1;

FIG. 3 is a perspective view of a first embodiment of a boot valveaccording to the invention;

FIG. 4 is a broken longitudinal cross-sectional view of the assembledcomponents of FIG. 2 and a standard male luer syringe positioned toactivate the valve;

FIG. 5 is a view similar to FIG. 4 showing the valve activated by thestandard male luer syringe;

FIG. 6 is a view similar to FIG. 2 showing the assembled components inconjunction with a multiple-access drug vial adapter;

FIG. 7 is a longitudinal cross-sectional view of a Y-injection portaccording to the invention;

FIG. 8 is a view similar to FIG. 2 illustrating an alternate spike body;

FIG. 9 is an enlarged side elevational view of a septum according to theinvention;

FIG. 10 is a section taken along line 10-10 in FIG. 9;

FIG. 11 is an enlarged side elevational view of an H-guide according tothe invention;

FIG. 12 is a top view of the H-guide of FIG. 11;

FIG. 13 is a section taken along line 13-13 in FIG. 11.

FIG. 14 is a side elevational view of a second embodiment of a bootvalve according to the invention;

FIG. 15 is a section taken along line 15-15 in FIG. 14;

FIG. 16 is an enlarged side elevational view of a female luer bodyaccording to the invention;

FIG. 17 is a section taken along line 17-17 in FIG. 16;

FIG. 18 is a side elevational view of a spike body according to theinvention;

FIG. 19 is a top plan view of the spike body of FIG. 18;

FIG. 20 is a bottom plan view of the spike body of FIG. 18;

FIG. 21 is an enlarged section taken along line 21-21 in FIG. 18;

FIG. 22 is a view similar to FIG. 2 illustrating a single piececombination septum and boot valve;

FIG. 23 is a longitudinal sectional view of a guide wire adapter for usewith the injection port system of the invention;

FIG. 24 is a top plan view of the guide wire adapter of FIG. 23;

FIG. 25 is a longitudinal sectional view of the guide wire adapter ofFIG. 23 coupled to an injection port system of the invention;

FIG. 26 is a longitudinal cross-sectional overlay of a spike body and aboot according to another embodiment of the invention;

FIG. 27 is a highly magnified view of the tip portion of the boot ofFIG. 26 showing radii, angles and dimensions;

FIG. 28 is a side view of the boot of FIG. 26;

FIG. 29 is a cross-sectional view of the boot of FIG. 26; and

FIGS. 30A and 30B are views of the inside surface walls of the boot atproximal and distal locations shown in FIG. 29.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Turning now to FIGS. 1-3, a first embodiment of a needle-freeintravenous injection port assembly 100 according to the inventiongenerally includes a spike body 102 provided with a hollow spike 104, afemale luer connector component 106, a flexible and resilient boot valve108, an H-guide centering member 110, and a resilient septum 112. Asseen best in FIG. 2, the boot valve 108 extends over the spike 104, theH-guide 110 is provided over a portion of the boot valve 108, and theseptum 112 is provided between the H-guide 110 and an end of the femaleluer connector component 106. The spike body 102 and the female luerconnector 106 are preferably made from a hard plastic material such aspolycarbonate and are welded, glued, or otherwise mated together duringassembly of the assembly 100. The H-guide 110 is preferably made from asemi-rigid plastic such as high density polyethylene. The boot valve 108and the septum 112 are preferably made from a rubber-like material, suchas synthetic polyisoprene or silicone rubber, having an approximately60-70 Shore A Durometer. The inside surface of the boot valve 108 ispreferably roughened by EDMing the injection mold core pin. Duringassembly of the assembly 100, the septum 112 and boot valve 108 arecompressed slightly, as the height of the female luer connectorcomponent 106 is slightly less than the height of the boot valve/septumcombination up to the shoulder 112 a of the septum 112. Thus, in anat-rest position, the boot valve is slightly compressed (as is theseptum).

According to the illustrated embodiment and as shown in larger view inFIG.3, the boot valve 108 is preferably configured with a helicalexternal surface 108 a and a radially enlarged portion 108 b. The septum112 is preferably provided with a shoulder 112 a, a tapered end 112 bfacing the boot valve, and a single continuous swabbable surface 112 cfacing away from the boot valve as described in more detail below withreference to FIGS. 9 and 10. The septum and the boot valve arepreferably pre-punctured with a knife blade having a width of 0.056″ byaligning the septum and the boot valve in the H-guide in a subassemblyand puncturing the septum and the boot valve in a pre-assemblymanufacturing process as described below. The H-guide 110 is preferablyprovided with a tapered internal surface 110 a, 100 b at both ends andits outer surface 110 c is polished very smooth as described in moredetail below with reference to FIGS. 11-13. The surface 104′ of thespike 104 is preferably roughened and is coated with a fluorosiliconelubricant 104″. The roughened finish 104′ may be achieved by severalmethods including, but not limited to, EDM, sandblasting, mediablasting, chemical etching, mechanical means, etc. The roughened finish104′ helps to “entrap” the lubricant 104″. The radially enlarged portion108 b of the boot valve 108 is preferably tapered to match the taper ofthe H-guide 110. The boot valve 108 and the septum 112 are preferablymated with mechanical interference.

Turning now to FIGS. 4 and 5, a needle-free syringe 10 has a male luertip 10 a which is matable with the female luer 106 of the invention. Themale luer tip 10 a is pressed against the swabbable surface 112 a of theseptum 112 and pushed down in the direction of the arrows shown in FIG.4. As the male luer 10 a is moved into the female luer 106, the septum112 and the boot valve 108 are moved over the spike 104 as shown in FIG.5. This opens a fluid path between the interior of the luer 10 a and theinterior of the spike 104 due to holes in the top of the spike asdiscussed below with reference to FIGS. 18-21.

FIG. 6 illustrates how the invention can be used with a multiple accessdrug vial adapter 12. The drug vial adapter 12 has a female luer 12 a atone end and a hollow spike 12 b at the other end. The male luer 102 ofthe injection port system 100 engages the female luer 12 a of the drugvial adapter and the spike 12 b of the vial adapter pierces the septumof a drug vial (not shown).

FIG. 7 illustrates a Y-site 200 incorporating an injection portaccording to the invention. The Y-site 200 has a Y-site base 202 whichincludes a spike 204 which is the same or similar to the spike 104described above. The remaining components are the same as describedabove. Those skilled in the art will appreciate that the Y-site isuseful when incorporated into an intravenous extension or administrationset to allow injections via the same intravenous line through theinjection port.

FIG. 8 illustrates an alternate embodiment of an injection port 300. Theinjection port 300 has a spike body 302 with a spike 304 which does nothave a point. It has, instead, an open tip 304 a. The remainder of thecomponents are the same as described above. This embodiment allows forthe passage of guide-wires and other implements through the valve asdescribed below with reference to FIGS. 23-25.

FIGS. 9 and 10 illustrate enlarged views of the septum 112. The septum112 has an upper frustum 112 d and a lower frustum 112 b of largerdiameter defining a shoulder 112 a. The upper end of the upper frustum112 d is a continuous convex surface 112 c. The lower frustum 112 bdefines a concavity 112 e which is dimensioned to fit the tip of theboot valve with mechanical interference.

The upper resilient septum 112 provides the first line of defenseagainst pathogen ingress into the fluid pathway from outside theinjection port, and the second line of defense against fluid leakage dueto high back pressure from inside the injection port. The septum is heldin the “H-Guide” 110 as shown in FIG. 2 with a dimensional interferencecausing a circumferential mechanical force to assist in resealing thepre-puncture (not shown) in the center of the septum and boot valveduring numerous activations. The outer shoulder or flange 112 a has alarger diameter than the opening of the female luer component 106 andthe upper frustum 112 d preferably makes an interference fit with thefemale luer opening as seen in FIG. 2.

As previously mentioned, the septum and boot valve are preferablypre-punctured prior to assembly of injection port with a lubricatedpiercing device. The pre-puncturing process is performed with theseptum, H-guide, and boot valve sub-assembly and a piercing device whichmoves through the two independent and adjacent resilient barriers untilthe piercing device is totally through the sub-assembly. The piercingdevice, preferably a 0.056 inch width stainless steel knife blade (butother appropriate piercing devices would be acceptable), pre-puncturesboth the boot valve and septum in a smooth, in-line, axis geometry. Thisnew smooth, in-line, axis geometry coupled with the fluorosiliconelubricant has reduced the required activation force to approximately 3.8lbs, making it easier to use. This manufacturing process modificationeliminates the jagged cuts, tears, and coring that was observed in theoriginal process utilizing the internal spike tip. The piercing deviceis lubricated preferably with a fluorosilicone lubricant which assistsin a smooth pre-puncture-axis geometry. The fluorosilicone formulationalso minimizes the “cross-linking” of the silicone molecular structureduring gamma radiation sterilization. It is understood that other FDAapproved lubricants could be acceptable for this application. Inaddition, in order to improve the “snap-back” characteristics of thisnew injection port, and to minimize frictional abrasions within the bootvalve during the compression or activation phase when the septum andboot valve move down over the internal spike tip and shaft, an inertlubricant is molded within the boot valve formulation. Syntheticpolyisoprene and silicone are the preferable materials in this injectionport due to their inertness, abrasive resistance, sealing and internalmemory characteristics, and their sterilization capability. It isunderstood that other inert resilient materials could be used for thisapplication.

Turning now to FIGS. 11-13, the H-guide centering member 110 includes agenerally tubular outer portion 110 c and an annular inner portiondefining a hole 110 d. The outer portion 110 c is sized to stablyaxially slide within the central portion of the female luer component106 as shown in FIG. 2. The outer portion 110 c and inner portiontogether define first and second substantially identical receiving areas110 a, 110 b. These areas have an outer tapered portion and an innernon-tapered smaller diameter portion. This assists in mating with theboot valve and the septum. The receiving areas 110 a, 110 b arepreferably provided with annular rings 110 e, 110 f which assist insealing the interface between the septum and the boot valve.

FIGS. 14 and 15 illustrate a second alternate embodiment of a bootvalve. The difference between this embodiment and those described aboveis that undulations 208 a are not helical but consist of a plurality ofnon-tapering projections arranged along the axis of the boot valve 208.Although this boot valve may not perform as well as the boot valve 108in terms of snap back and activation force, it does retain theadvantages of the frustum 208 b, the dimensions of the tip 208 c, andthe sealing ring 208 d which helps seal the space between the boot valveand the spike shaft.

FIGS. 16 and 17 illustrate enlarged views of the female luer component106. The female luer connector component 106 is tubular and includes afirst open end 106 a, a female luer second end 106 b, and a centralportion 106 c therebetween. The first end 106 a includes a flange 106 dwhich is preferably provided with an annular mating ridge 106 e. Theridge defines an enlarged diameter relative to the central portion 106c, and is provided on the flange 106 d directed away from the second end106 b. The mating ridge 106 e is sized and shaped to be received in theannular mating slot of the spike body 102 (described below withreference to FIGS. 19 and 21). The second end 106 b includes an openinghaving a reduced (relative to the rest of the component 106) with atapered portion 106 f and a non-tapered portion 106 g. The tapered andnon-tapered portions provide a better sealing fit with the septum 112 asshown in FIG. 2. A luer lock thread 106 h is preferably provided aboutthe second end 106 b.

The internal wall 106 j of the component 106 is preferably smooth andslightly tapered up to a perpendicular wall 106 k, leading to an openingapproximately 0.180 inch diameter which preferably tapers toapproximately a 0.164 inch diameter in the second end 106 b of thefemale luer body component. The internal wall is preferably smooth toallow the H-guide component to axially move without obstruction duringthe compression and snap-back phases. It is understood, that a flutedinternal wall structure could also be acceptable.

FIGS. 18 through 21 illustrate the spike body 102 in greater detail. Thespike body includes a first end 102 a having a male luer connector 102b, the spike 104 preferably integrally formed with the body 102 andcoaxially directed opposite the male luer connector 102 b, and a base102 c at the juncture of the male luer connector 102 b and the spike104. A fluid path 105 is provided through the spike 104 and male luerconnector 102 b. The spike 104 has a tapered shaft 107 leading to abullet-nose arched tip 109 which defines a second end of the spike body102. The tip 109 includes a plurality of slots (e.g., three slots) 104 awhich provide access into the hollow 105 of the spike 104 from outsidethe spike. The shaft 107 includes a base portion 107 a which has anenlarged stepped diameter for holding the boot valve thereabout. Thebase 102 c of the spike body 102 also includes an annular groove 102 dwhich receives the mating ridge 106 e of the female luer component 106.The base 102 c preferably also includes a plurality of internal threads102 e which together with the male luer connector 102 b function as amale luer lock. In addition, the periphery of the base 102 c includes aplurality of molded longitudinal ridges 102 f to facilitate engagementof the periphery of the spike body by human fingers.

As mentioned above, a preferred embodiment of the integral spike shaftand spike tip used in the present invention is configured with aroughened finish external surface and a fluorosilicone liquid lubricateused along the shaft and tip. The roughened finished external surfacecreates a roughened surface with approximately 0.001 to 0.002 inch depthareas allowing for a circumfluent flow of the liquid lubricant along thespike shaft and spike tip. The previously incorporated co-ownedinvention had a very smooth external spike shaft surface with a Dow 360silicone lubricant. This smooth surface caused on occasion a “suction”affect between the internal wall surface of the boot valve component andthe spike shaft. The roughened finish allows the lubricant to flow intothe 0.001-0.002 inch impressions on the spike shaft, eliminating the“suction” effect seen in the prior invention, and maintaining adequatelubrication between the internal wall of the boot valve and spike shaftduring numerous compression and snap-back cycles of the valve. Thissurface improvement also enhances the “snap-back” feature of the valve.

From the foregoing, it will be appreciated that the female luer 106, theseptum 112, the H-guide 110, the boot valve 108, and the spike 104interact as described below to obtain numerous advantages. The septum112, by being properly dimensioned and entrapped within the female luercomponent when in the assembled slightly compressed state passes a 30psi backpressure test, thus improving the prevention of fluid leakagefrom the injection port. It also provides a primary seal surface tofurther prevent gross particulate contamination from entering into thebody of the injection port, thus preventing pathogen ingress into thepatient's blood stream. Further, the interference fit between the septumand the female luer increases the circumferential mechanical force toimprove the resealing of the pre-puncture in the center of the septum inthe assembled slightly compressed state. In addition, as discussedbelow, these elements help assist in obtaining a zero fluid displacementfor the assembly.

The taper of the lower frustum 112 b assists in the assembly of theseptum in the H-guide 110. The lower frustum 112 b also has a largerdiameter than the matching inside wall diameter of the H-guide causing amechanical interference. This mechanical interference frictionally holdsthe septum into the H-guide.

The interior cavity 112 e of the septum has a matching contour to thetip of the boot valve 108. The diameter of this cavity is smaller thanthe tip of the boot valve, causing a circumferential mechanical fitagainst the pre-puncture in the boot valve. This new design eliminatesany interstitial cavity chamber or dead space between these twointerfaces thus assisting in achieving a “zero fluid displacement” whenthe valve is moved from the assembled slightly compressed state to thecompressed state and vice versa. The interference fit between the septumand the tip of the boot valve also improves the performance of theinjection port in the assembled slightly compressed state in thefollowing ways. There is improved resealing of the pre-puncture in thecenter of the boot valve, improved prevention of pathogen ingress intothe patient's bloodstream through the pre-puncture in the boot valve,and improved prevention of fluid leakage from the patient's side of theinjection port.

Another design modification that improves the overall performance ofthis new injection port is the provision of a single continuousswabbable surface on the proximal side of the septum. In addition, allof the external surfaces of the septum that come in contact with theH-Guide and the boot valve are smooth to assist in the sealingcharacteristics between these component interfaces.

The new H-guide centering component assists in the new designenhancements and improvements. The H-guide contains both the upperresilient septum and the lower resilient boot valve. The outer diametersof the septum and the boot valve are larger than the inner walldiameters of the H-guide where they interface, giving a frictionalinterference fit between all components. The H-guide centering componentis also shaped similar to the lead-in tapers of the septum and the bootvalve for ease of assembly. The dimensional mechanical interferencebetween the septum and the H-guide applies a mechanical pressure againstthe pre-puncture axis of the two independent and adjacent resilientbarriers, thereby improving microbial ingress prevention, improvingfluid leakage prevention, and assisting in eliminating the dead spacebetween the septum/boot valve and boot valve/spike tip interfaces toachieve zero fluid displacement during the compression and snap-backcycle. The H-guide also prevents the two resilient barriers from comingin contact with the female luer inner wall, thereby eliminating anyfrictional abrasion during the compression and snap-back cycle of theresilient barriers rubbing against the inner wall of the female luerbody element, thereby, improving the snap-back capability of the valve.The H-guide also keeps the septum and boot valve in-line puncture axisgeometry “centered” over the stationary spike tip and shaft, preventingjagged cuts, tears, or coring of the two resilient barriers. The outerdiameter of the H-guide is slightly smaller than the inside diameter ofthe female luer body, allowing for a smooth axial movement of the valveduring compression and snap-back cycle. A preferred material for theH-guide is high-density polyethylene due to its lubricitycharacteristics, but other plastic materials could function in thisapplication.

FIG. 22 illustrates another embodiment of an injection port 400according to the invention. This embodiment differs from the firstembodiment in that the boot valve 408 and the septum 412 are a singlepiece. All of the other components are the same as the first embodiment.

FIGS. 23 and 24 illustrate a guide wire adapter for use with aninjection port according to the invention. The guide wire adapter 500includes a male luer base 502 and an elongated female luer body 504coupled to the male luer base with a thin silicone resilient disk 506therebetween. The disk is preferably pre-punctured in its center. Thesilicone disk prevents air ingress into the patient's blood stream andprevents blood egress from the device during guide-wire applications.The female luer body 504 has a tapered inner bore 508 which is coaxialwith the bore of the male luer 502. The exterior of the female luer body504 is fluted as shown in FIG. 24. When the guide wire adapter 500 iscoupled to an injection port 300 of FIG. 8 as shown in FIG. 25, a guidewire 20 may be inserted through the adapter into and through theinjection port.

Turning now to FIG. 26, another embodiment of the boot and spike of theinvention is seen. In FIG. 26, the boot 608 and spike 604 are shown intheir preassembled state as an overlay of each other. Thus, at the areadesignated A, the base 608 e of the boot is shown extending down below(interfering with) the top surface 602 f of the lower luer portion ofthe spike, whereas, in reality, when assembled, the base 608 e of boot608 must rest atop the surface 602 f with the inner surface of the bootfrictionally fitting on the widened base 607 of the spike (see, e.g.,FIG. 2). Similarly, at the area designated B, the tip 609 of spike 604interferes with the tip 608 c of boot 608. This is best appreciated byunderstanding that the outer line marked “a” is the outer surface of theboot 608; the next line inward from line a is marked “b” and is the topof tip 609 of the spike; and the next line marked “c” is the interiorsurface of the tip 608 c of boot 608. When assembled, the spike tip willbe within the boot (see, e.g., FIG. 2) and there will be no gap betweenthe spike tip and the boot tip. A third area of interference seen is atthe area designated C. However, when the boot 608 is placed on the topsurface 602 f of the lower luer portion of the spike, that interferencedisappears. In fact, a small clearance is provided between the spike andthe boot along the length of the spike between the base 607 of the spikeand the sealing ring 608 d in the tip area 609. This clearance permitsthe boot to be relatively easily compressed without much friction whenthe tip 608 c of the boot 608 is forced over the spike tip during use.

Turning now to FIGS. 27-30A and 30B in conjunction with FIG. 26, it willbe appreciated that boot 608 is a helically threaded boot as in theother embodiments of the invention. However, boot 608 differs from theother helically threaded boots in three manners. First, as seen best inFIGS. 28 and 29, the outer surface 608 a of the threaded portion of theboot 608 does not taper at all. In fact, any horizontal cross-sectionthrough the threaded portion of the boot 608 will show that the distancefrom one side of the boot to the other is constant. Second, as seen bestin FIGS. 30A and 30B, the inside surface of the threaded portion of theboot is configured as an octagon (although other polygons such as ahexagon, pentagon, square, etc. could be utilized) such that there iseffectively no diameter to the inside and such that the points ofcontact during compression of the boot over the spike are reduced. It isnoted that the tip portion of the boot maintains its circular insidesurface. Third, as seen best in FIGS. 26 and 29, the wall thickness ofthe boot generally increases as the boot goes from its base toward itstip. Thus, just above its base, the octagonal area bounded by the insidesurface of the boot (FIG. 30B) is larger than the octagonal area boundedadjacent the tip (FIG. 30A). It has been found that the boot 608provides less resistance to the mating connection of a syringe luer tothe injection port valve system of the invention (i.e., a loweractivation force by approximately 50% relative to the boot of previouslyincorporated U.S. Pat. No. 6,113,068), and provides better snap-backaction.

Another difference between the embodiment of FIG. 26 and otherembodiments is that the spike 604 does not taper much towards its tipend, and then has a middle section which flares outwardly. Thisarrangement permits the assembly to be used with mini-volume extensionsets (used with IV syringe pumps). Other aspects of the boot 608 andspike 604 are the same as in the other embodiments. For example, theboot and spike are made of the same materials as disclosed withreference to the other embodiments, the surface of the spike 604 ispreferably roughened and is coated with a fluorosilicone lubricant, etc.With the spike and boot of FIG. 26, a zero fluid displacement system isobtained with a connection displacement of 0.000 mL−0.000 and +0.002 mLand a detachment displacement of 0.000 mL±0.000 mL.

There have been described and illustrated herein several embodiments ofmedical intravenous administration injection ports. While particularembodiments of the invention have been described, it is not intendedthat the invention be limited thereto, as it is intended that theinvention be as broad in scope as the art will allow. Thus, it will beappreciated by those skilled in the art that the term “intravenousfluid” is intended to be understood in a broad sense to includeparenteral fluids including drug solutions, blood, blood products, dyes,or other fluids and the term “administration” is used in its broad senseto include the dispensing or collection of the “intravenous fluid”.Further, while the injection port is illustrated as preferably having afemale luer lock on one end, and a male luer lock on the other end, itwill be appreciated that, although not preferred, simple luer slipscould be utilized in lieu of luer locks. Furthermore, while a ridge andgroove are disclosed for mating the female luer component and spike bodytogether, it will be appreciated that other mating means may be used.For example, a plurality of mating tabs and slots, or ridges andgrooves, or the like, may be used. Moreover, while a particular plasticmaterial has been disclosed for the spike body, female luer component,and centering member, it will be appreciated that other rigid materialsmay likewise be used for these components. Also, in each embodiment thespike may be unitary with or of a separate construction than the body.Furthermore, while particular rubber-like materials have been disclosedfor the boot valve and septum, it will be appreciated that otherrubber-like materials of different Durometers may also be used. Furtheryet, while the boot valve and septum are described as preferably beingpre-punctured with a knife blade, it will be appreciated that, ifdesired, neither the boot valve nor the septum need be pre-punctured, oronly one of them might be pre-punctured, and that they may bepre-punctured with a solid core needle or other means. Alternatively,although not preferred, the boot valve and/or septum may be pre-slit;i.e., injection molded with a horizontal slit therein. Pre-slitting theboot valve and/or septum is not preferred as during use the pre-slitboot and/or septum will not accommodate the spike as well as apre-punctured boot and/or septum. It will therefore be more prone totearing, thereby leaving the pre-slit device more prone to undesirablemicrobial migration. Also, while a boot valve having an outer helicalsurface and a linear and tapered inner surface has been shown, it willbe appreciated that the boot valve could also have a helical inner orother non-linear or non-tapered surface. Therefore, it will beappreciated by those skilled in the art that yet other modificationscould be made to the provided invention without deviating from itsspirit and scope as so claimed.

1. A method for coupling and uncoupling a device to a fluid pathway,said method comprising: coupling an injection port assembly having aresilient valve to the fluid pathway, coupling the device to theinjection port assembly such that the resilient valve is opened puttingthe device in fluid communication with the fluid pathway with zero fluiddisplacement during coupling; and uncoupling the device from theinjection port assembly such that the resilient valve is closed and thedevice is no longer in fluid communication with the fluid pathway withzero fluid displacement during uncoupling, wherein said resilient valveis a compressible pierceable boot valve with a tip portion, and saidinjection port assembly includes a body around said boot valve and aspike within said boot valve, wherein when the device is coupled to saidinjection port assembly, said tip of said boot valve is forced over saidspike.
 2. A method for coupling and uncoupling a device to a fluidpathway, said method comprising: coupling an injection port assemblyhaving a resilient valve to the fluid pathway, coupling the device tothe injection port assembly such that the resilient valve is openedputting the device in fluid communication with the fluid pathway withzero fluid displacement during coupling; and uncoupling the device fromthe injection port assembly such that the resilient valve is closed andthe device is no longer in fluid communication with the fluid pathwaywith zero fluid displacement during uncoupling, wherein said injectionport assembly includes a body and a spike within said body, and when thedevice is coupled to said injection port assembly, said resilient valveis pierced by said spike.
 3. A method according to claim 2, wherein:said spike and resilient valve are arranged so that there is no deadspace for fluid between said spike and resilient valve when the deviceis in fluid communication with the fluid pathway and when the device isno longer in fluid communication with the fluid pathway.